Acts Online
GT Shield

Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Regulations

General Regulations

Registration of Medicines

9. Categories and classification of medicines

 

(1) Medicines shall be classified into categories as follows:
(a) Category A = Medicines which are intended for use in humans and which are, without manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine;
(b) Category B = Medicines intended for use in humans and animals which cannot normally be administered without further manipulation;
(c) Category C = Medicines intended for veterinary use which are, without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine; and
(d) Category D = Complementary medicines intended for use in humans and animals which are, without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine.

 

(2) Medicines in Category D shall be classified into the following sub-categories:
(a) discipline-specific medicines with such disciplines as determined by the Authority; and
(b) health supplements.

 

(3) Medicines in Categories A and D (human complementary medicine) are subdivided into classes as per Annexure 1.

 

(4) Medicines in categories C and D (veterinary complementary medicines) are subdivided into classes as per Annexure 2.